Compliance helps healthcare organizations mitigate risk by building strong relationships and leading through influence for effective regulatory change management
Continue readingFour Power Skills for Influence
Beneficiary inducements…don’t cross that line
Illegal beneficiary inducements include: free insulin, deflated Medicare copayment, courtesy adjustments for injections, free glucometers and waived co-payments
Continue readingBeneficiary inducement rule changes promote coordinated care
The OIG’s Beneficiary Inducement Final Rule is part of HHS Regulatory Sprint to Coordinated Care – Advancing the transition to value-based care.
Continue reading12 key metrics for compliance officers looking to move their culture forward
Culturally impactful metrics emphasize getting healthcare compliance officers in the right rooms – ahead of regulatory change or organizational growth.
Continue readingRelaxed beneficiary inducement rules address pandemic need
Rules relaxed for arrangements directly connected to COVID-19. OIG considers intention of incentives under the beneficiary Inducement rules.
Continue readingStark Law: Flexibility for value-based care
The well-intentioned but complex Stark Law has gotten some updates recently. The changes give healthcare providers greater flexibility, especially with value-based care.
The Stark Law was introduced in 1989 by United States Congressman Pete Stark (D-CA). It aims to protect Medicare and Medicaid from paying for services that may trigger conflict-of-interest concerns. This includes certain healthcare services for which physicians referred their Medicare/Medicaid patients to an organization with which they have a financial relationship. Referrals like this trigger questions about whether the patient really needed the service and raises concerns of physicians referring for their own financial benefit.
Take, for example, a physician who refers a Medicare/Medicaid patient for an x-ray to a medical imaging facility. The facility then bills Medicare for that service. This may seem appropriate unless the physician has a financial interest in the medical imaging facility.
The law faced criticism, however, for being too rigid. According to Henry Casale, partner at Horty Springer, “providers have found that the Stark Law is deceptively simple to summarize, but compliance has proven to be difficult and complex.”
Casale went on to say that “Stark said that ‘the only way to protect healthcare consumers from unnecessary referrals is to impose a bright line rule.’ The Stark Law prohibits a physician from making referrals for certain Designated Health Services (DHS) payable by Medicare or Medicaid to an entity with which the physician (or an immediate family member) has a direct or indirect financial relationship (ownership or compensation). It also prohibits the entity from filing claims with Medicare or Medicaid for those referred DHS, unless the financial relationship complies with an exception to the Stark Law.”
New value-based exceptions
New exceptions under Stark allow for physicians to refer Medicare/Medicaid patients to entities they have a financial relationship with and that are part of a value-based program, in some cases. Additionally, the physician may receive remuneration, such as cost savings payments, so long as the requirements of the new exception are met.
According to Casale, “The Stark value-based rules cover both cash and in-kind remuneration and do not include the term ‘Fair Market Value’.” These rules have a number of requirements, but those requirements decrease as the value-based physician participants assume more financial risk. The greatest flexibility is when the physician participants agree to assume full financial risk. (This includes capitation and global budget payment arrangements.) The requirements increase if the physician participants assume only “meaningful” financial risk. (The physician is responsible to repay or forego no less than 10 percent of the total value of the remuneration the physician receives under the value-based arrangement.) The requirements are greatest where the physicians are not at financial risk.
“The Stark value-based rules are a significant improvement,” Casale said. “But they do leave a number of questions unanswered.” They also differ markedly from the OIG’s value-based safe harbor regulations that were published the same day, especially where the physicians are not at financial risk. Here the OIG only provides safe harbor protection for in-kind remuneration while the Stark rules permit both cash and in-kind remuneration.
“So while the Stark rules provide guidance and significant flexibility,” Casale said, “providers need to also consider the OIG’s much more narrow view of value-based arrangements.”
Related: Discover how CMS is improving patient care while reducing administrative burden for providers.
Rules related to Stark and anti-kickback legislation have been evolving for decades. These recent changes reflect an effort to add greater flexibility with value-based care and help keep the law responsive to current business practices in healthcare.
How is your healthcare system adapting to keep up with changes to rules from the Stark Law and other fluid regulations? Read more about how YouCompli can help you stay on top of regulatory changes or schedule a demo.
Jerry Shafran
Jerry Shafran is the founder and CEO of YouCompli. He is a serial entrepreneur who builds on a solid foundation of information technology and network solutions. Jerry has founded, managed, and sold software and content solutions that simplify complex work. His innovations enable professionals to focus on their core business priorities.
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Six key steps to reduce the impact of telehealth audits
Telehealth is almost as old as the telephone itself. In 1879 – just three years after Bell patented the telephone – an article in Lancet described the concept and advocated its adoption.
A law that’s even older can trigger many telehealth audits today. The 1863 False Claims Act (FCA) was enacted to keep profiteering contractors from defrauding the Union army. It can trigger serious problems for hospitals that don’t take proactive steps to make sure their telehealth practices are audit-proof.
That’s because the 2010 Affordable Care Act updated the FCA to make healthcare providers liable for “retention of any overpayments” from Medicare and Medicaid. This even includes overpayments resulting from accident or error. Indexing penalties for inflation each year, a requirement added in 2015, increased hospital liabilities. This puts liabilities at three times the amount of the overpayment(s) plus $11,803 to $23,607 for each instance. (Some 29 states and the District of Columbia have additional False Claim laws.)
These laws’ implications and requirements touch every part of the hospital. Keeping the whole organization in compliance means that all departments have to work together.
New laws, new regs, new worries for telehealth
Even before COVID, the government audited claims from what was then a smaller, rural telehealth system. Regulators found a trend of incorrect payments to doctors outside rural areas, who were therefore ineligible to receive them.
Telehealth is on the latest Office of the Inspector General (OIG) work plan, too. The OIG will be addressing remote patient monitoring by telehealth as an area of concern.
The public health emergency, with its series of 90-day waivers, made it possible for telehealth to grow so fast. Now, as the COVID emergency ebbs, Congress is considering making its current, expanded status permanent. (Two bills were introduced in May. One would enable audio-only telehealth services for Medicare enrollee. The other would expand telehealth for Medicaid and Children’s Health Insurance Programs.)
That’s good. But with laws come regulations covering acceptable types, locations and forms of delivery of telehealth services. And with regulations come scrutiny and audits. That can create challenges, especially with the specter of FCA liability in the background.
The best way to cope with audits is to prevent the need for them in the first place. Here are six steps to follow:
- Know what you’re up against. Keep up to date with all the developing federal and state regulations, waivers, and other requirements. That in itself can take up most, if not all, of your personal and your compliance team’s time.
Related: Find out how a team of expert compliance professionals and a nationally respected law firm track and analyze the latest regulatory changes, keep you updated, and give you actionable ways to adapt your process.
- Inventory your waivers. Which waivers do you rely on, in which departments and facilities? Do the providers and staff that they apply to know about them? And who makes sure the requirements are met and documents it?
- Check your records. One of the biggest causes of noncompliance isn’t malice. It’s error. Did an accidental typo in Coding result in an incorrect claim? Does everyone in Billing know which states require what reimbursement levels for telehealth services? Are certain telehealth records missing? Who’s responsible for keeping the signed doctors’ orders and documents that establish medical necessity? Do patients and services meet billing guidelines? Do you have a telehealth compliance policy? Does it need changing? Start conducting spot-checks to find out.
Related: Find out about state requirements for telehealth billing.
- Audit your process. Another big cause of noncompliance is miscommunication – particularly the assumption that someone else is taking care of something. So put together an internal audit team, with each department represented. That way, each can learn from the other. Hold an entrance conference to highlight what you learned from your spot checks, define the internal audit’s scope, set expectations, and assign specific tasks and timelines.
- Fix whatever’s broken. Reconvene the internal audit team and communicate the findings. Together, use that input to find opportunities to correct or cure what’s wrong in your process. Then, create a Corrective Action Plan (CAP) that will include needed education, training, policy, and process changes. Monitor your CAP over time, to see how it’s working and to spot anything else that needs fixing.
- Rebill and repay. If your internal audit and CAP were successful, you’ll have discovered missing or insufficient documentation. Report it. You may have also have found instances of incorrect payments. Rebill and repay. Yes, it will cost your hospital money. But not nearly as much as a full-blown government audit. A Department of Justice investigation could end up costing you time, legal fees, and FCA triple damages.
Patient demand for telehealth isn’t going away. Neither are the costs of noncompliance with telehealth regulations. As the public health emergency expires, fines from regulators and denial of claims from payers are sure to add up. The best way for your healthcare organization to solve these potentially massive financial problems is to work together to prevent them. Proactively partnering with colleagues in all relevant departments, your compliance team can lead the efforts to identify and fix issues before they become major problems. That way, you’ll be able to provide the telehealth services patients want in compliance with what the regulations demand.
It’s a big effort to keep your compliance champions connected and communicating. See how YouCompli can help you manage the rollout of new regulations and verify best efforts to regulators and your board. YouCompli is the only healthcare compliance software combining actionable regulatory analysis with a simple SaaS workflow.
Communicating Compliance Terms in Plain English…
If you have ever been new to a particular field of the workforce, such as healthcare compliance, you know all too well that the language used by coworkers can sound foreign, like gibberish, or “alphabet soup.” As we continue to work in the field though, we too, start speaking the language. However, while that may be ok for conversing in the compliance department, it still be confusing if we are trying to communicate with, or to educate, other functional areas of the healthcare organization. Without knowing the terminology, the message we are trying to convey is unlikely to be understood when received.
Alphabet Soup
Take a look at an example of terminology just starting with the letter “A” from the Office of the Inspector General Work Plan (reference below):
- ADAP AIDS Drug Assistance Program (note this one includes an abbreviation in the definition);
- AI/AN American Indians and Alaska Natives (I, for one, was unfamiliar with this abbreviation);
- AIDS acquired immunodeficiency syndrome;
- ALF assisted living facility;
- ALJ administrative law judge;
- AMD age‐related macular degeneration (while I have heard of macular degeneration, I did not know this was a standard abbreviation);
- AMP average manufacturer price;
- ASC ambulatory surgical center;
- ASP average sales price; and
- AWP average wholesale price.
Say I am talking to another seasoned compliance professional in front of a new employee. Using the above “A” acronyms only, the conversation may sound something like this,
“Based on the billing audit, I see we are not receiving contracted AWP reimbursement under our AI/AN contract for ALF patients with AMD.”
As you can imagine, a new employee might be confused by the acronyms and terms communicated instead of using common business English. Sometimes just saying the entire word instead of the abbreviation is a good place to start, so instead of saying AWP say average wholesale price.
Repetitive Communication
In order to improve communication between seasoned compliance professionals and other members of the organization, it is important to use repetitive teaching strategies. In addition to saying the entire compliance term and the abbreviation, be repetitive and write out the compliance term in addition to the abbreviation in written communications. That way staff become more familiar with compliance terminology and it becomes a part of their daily vocabulary.
Knowledge in Practice
When it comes to any industry, including healthcare, it is easy to throw around acronyms and jargon that is familiar and efficient. However, it is important to be aware of who you are talking to, and therefore make sure they clearly understand whatever it is you are communicating. Translate and reword industry terminology in emails, policies and teaching materials where necessary in order to improve communication and understanding. Better compliance will ultimately be the result.
PRACTICE TIP:
- Regularly evaluate training and orientation materials to ensure industry specific terminology is defined and understandable.
- Utilize the youCompli system as a centralized hub for new and existing compliance processes and utilize the included model procedures throughout the various areas of your organization.
RESOURCES:
Health Care Compliance Association (HCCA) Compliance Dictionary found at https://www.hcca-info.org/publications/compliance-dictionary
Health and Human Services (HHS), Office of the Inspector General (OIG), Work Plan Appendix B: Acronyms and Abbreviations found at https://oig.hhs.gov/publications/workplan/2011/wp09-appx_b_acronyms.pdf
Denise Atwood, RN, JD, CPHRM
District Medical Group (DMG), Inc., Chief Risk Officer and Denise Atwood, PLLC
Disclaimer: The opinions expressed in this article or blog are the author’s and do not represent the opinions of DMG.
Denise Atwood, RN, JD, CPHRM has over 30 years of healthcare experience in compliance, risk management, quality, and clinical areas. She is also a published author and educator on risk, compliance, medical-legal and ethics issues. She is currently the Chief Risk Officer and Associate General Counsel at a nonprofit, multispecialty provider group in Phoenix, Arizona and Vice President of the company’s self-insurance captive.
Growth in Telemedicine Could Mean Trouble if You Are Not Careful
We can all agree that 2020 was a year filled with surprises. The emergence of COVID-19 brought restrictions, which made the business of healthcare even more challenging. But then came the saving grace: telemedicine!
Even though telemedicine has been around in some form since the 1900s, its popularity exploded during the midst of the pandemic. With millions of people stuck indoors due to government lockdowns, health care providers turned to telemedicine options to provide desperately needed health care.
According to Doximity, a social media networking service for medical professionals, only 14 percent of Americans utilized telemedicine before the pandemic. But since the outbreak, telemedicine usage skyrocketed by 57 percent. Among patients suffering from chronic conditions, the number of virtual care visits increased by a staggering 77 percent!
The increase in telemedicine accessibility also means healthcare providers can potentially face compliance issue pitfalls, which could land them in trouble with the United States government. Before COVID-19 became a household name, Medicare and Medicaid upheld strict rules regarding payment for telemedicine services. For instance, reimbursement for telemedicine services was limited to patients residing in areas of the country with limited healthcare.In an attempt to slow the spread of COVID-19, government payors loosened these restrictions.
Unfortunately, telehealth services’ widespread use brought an uptick in COVID-19 related scams that specifically target healthcare providers offering this service. Such illegal activity caught the attention of the Department of Justice (D.O.J.).
A primary focus of the D.O.J. is a government agency that mostly focuses on telehealth arrangements that implicate the Anti-Kickback Statute. The statute forbids transactions designed to corrupt medical judgment by rewarding referrals for Medicaid and Medicare services. In the past year, more than $4.5 billion in false claims were connected to telemedicine. And over 100 healthcare professionals were charged with submitting fraudulent claims to Medicare, Medicaid, and private insurance companies.
New changes to the Stark and Anti-Kickback Statutes that were long in the works took effect on January 19, 2021. The regulation updates are designed to eliminate regulatory and administrative barriers that hindered movement towards a value-based health care system. The updated rules also offer healthcare providers more flexibility to coordinate and improve patient care while maintaining safeguards against overutilization and inappropriate incentives.
The Stark Exceptions finalized three new exceptions for value-based arrangements between healthcare providers and payor systems like Medicaid and Medicare. These exemptions are solely based on the quality of delivered patient care instead of the volume of services. For example, healthcare providers face at least a 10 percent financial risk for failure to achieve value-based goals. In comparison, the Anti-Kickback Statute requires at least a 5 percent financial risk for value-based arrangements.
Physicians’ practices should express caution when offering telemedicine services to steer clear of trouble with the government. As with traditional in-person healthcare, it’s best to avoid doing business with third-party companies that give money in exchange for referrals.
Here are a few guidelines physicians should consider avoiding getting on the D.O.J.’s naughty list.
- Consult with counsel before entering into any outside business relationships.
- Establish guidelines for physical examinations and prescribing practices.
- Monitor the prescribing habits of their physicians and nurse practitioners.
- Adopt data analytic tools to identify any abnormal billing behavior.
Physicians considering telemedicine should also consider the following tips to stay compliant.
Practicing Telemedicine Across State Lines.
Usually, state governments require practicing physicians to conduct telemedicine sessions within the state they are licensed. But in some states, this stipulation is relaxed due to COVID-19 to make healthcare more accessible. But physicians must contact their state’s medical board for updated information concerning this topic.
Informed Consent.
Healthcare providers are still expected to obtain consent before providing telehealth services. Besides requesting written or verbal consent from patients, providers should make patients aware of the risks and benefits of receiving telehealth services.
Use Caution When Prescribing Medication.
Because of COVID-19, the Drug Enforcement Administration (D.E.A.) allows registered practitioners to use prescribed medication to patients via telemedcicine technology. Physicians must adhere to the following conditions:
- Prescribed medication(s) must be for a legitimate medical purpose.
- The telehealth session is conducted using a two-way, audio-visual, interactive communication system.
- The practitioners must practice healthcare within Federal and State law.
Only time will tell whether or not telemedicine will continue to grow in the upcoming months. But doctors should continue to use caution when using this technology to serve the public.